The invention relates generally to methods and devices for treating involuntary incontinence. More particularly, it relates to treatments which act to rapidly program the brain to counteract incontinence, such as wetting and soiling.
The existing methods and devices for curing incontinence are based on the establishment of behavioral conditioning. However, the known devices and methods have a major shortcoming—a treatment period extending over three months to one year. Analysis shows that these methods and devices do not comply with a basic property of the learning process: the existence of two periods in the cortical response to novel stimuli—a short phasic period, of about two seconds, which occurs during and immediately after the presentation of a novel stimulus, and a more prolonged tonic period, which last several minutes. (Sebastian Peter Grossman, A Textbook of Physiological Psychology, page 644, John Wiley & Sons, Inc.) Behavioral conditioning established during the phasic response time is very durable and resistant to habituation, whereas a behavioral conditioning established during the tonic period habituates rapidly. (Habituation is a learning mechanism not to transfer or not to respond to sensory information).
Non-compliance with this basic property of the learning process causes the inadequacy of all existing methods and devices for curing the incontinence disorder which operate by audio, light or vibratory signals, as they do not arouse the brain sufficiently fast to the necessary degree to be able to connect the arousing signal with the incontinent release of bodily wastes during the phasic period. This is particularly the case with the patents and devices which use wired or radio transmitting devices to alert attendants at remote location, causing them to rush to wake up the wetting person. These signaling devices require many months to cure incontinence. From the studies of behavioral conditioning, it has been experimentally proven that even a well-established conditioned response cannot be elicited while the subject is asleep (Loucks, R. B., J. Comp. Psychol., 25:415-426 (1938)). The signaling devices do not rouse the sleeping brain.
It has been proposed to apply an electric pulse to the human body. Such applications exist in Danish Patent No. 97424 and U.S. Pat. Nos. 3,870,051, 4,205,671, 6,407,308 B1 and 6,570,053 B2.
Danish Patent No. 97424 discloses an extremely high voltage of 400-900 volt with (column 2, line 17) an applied impulse of ultra short duration of 1/200 to 1/300 second (column 2, line 16) which, however, excludes the participation of the brain. The lack of application of consecutive electrical pulses fails to establish behavioral conditioning which is obligatory for achieving durable healing of the incontinence disorder.
U.S. Pat. No. 3,870,051 is based on an imposed urinary control by an externally located radio transmitter which operates a receiver and electrodes implanted in the body to the third and fourth, left and right sacral ventral motor nerve fibre roots (column 1, lines 27 to 29: column 5, lines 3 to 6) making possible a differential stimulation of the bladder and sphincter muscles. The operatively implanted electronic device which includes a power source, two radio receivers, a multi-vibrator and two electrodes is not created for the establishment of a behavioral conditioning, but for a permanent forced control operated by an external radio transmitter (column 2, line 66). If the device remains switched to a bladder hold mode, an outflow of urine will be prohibited, thereby adversely affecting the health of the patient. It is not by coincidence that the patent was developed on monkeys (baboons).
U.S. Pat. No. 4,205,671 to Lassen, et. al. employs a temperature sensor for a bed wetting device instead of one based on electrical contact. This prolongs the time between the onset of the wetting and the activation of the device as the temperature has to reach a predetermined level which exceeds the phasic period, optimal for the establishment of a durable behavioral conditioning. The device includes a timer circuit for a time delay control to delay the onset of the electrical pulse (column 5, lines 9 to 16). The pulse shock has a duration of less than 50 milliseconds “whereby the muscle of the bladder is closed as desired without the pulse attending the central nervous system. Thus, the patient or user will not feel the shock . . . ” (column 5, lines 29 to 30). The failure to rouse the brain excludes the establishing of a behavioral conditioning.
U.S. Pat. Nos. 6,407,308 B1 and 6,570,053 B2 to Roe, et. al. are almost identical, using the same proactive sensor and differing only in that the second patent includes soiling. Adapted to contain, isolate and dispose of bodily wastes, both patents offer ways to predict their imminent release by using sensitive sensors and a receiver to detect the change of the electrical signals originating from the sphincters. An actuator supported by a controller performs a variety of responsive functions based mainly on a release of different substances. A responsive function of special interest to the present patent application is the release of electrical signals to the sphincter muscles. Aiming only to prevent an imminent release of bodily wastes, the electrical signals applied in U.S. Pat. No. 6,407,308 are described as follows: “While the maximum strength of the electrical impulse may be as high as about 35 Volts, the electrical impulse preferably has a voltage in the range of about 0.05 to about 5 Volts and more preferably in the range of about 0.3 to about 1 Volt . . . ” (column 23, lines 39 to 43). The strength of the pulses of 5 volt can stimulate only a simple local anorectal reflex which represents a reflex arc completed only in the spinal cord as a segmental reflex, without the participation of the brain. The proof that all neural vents described in the Roe, et. al. patents are only on local and not on brain level comes from the acknowledgment, Roe '308 at column 23, lines 28 to 29, “This process may be alternatively referred to as dynamic graciloplasty nerve stimulation”, as well as by the fact that in the Roe patents the brain is not mentioned.
Arousing the brain requires about ten times higher strength of the impulses than applied in the Roe, et. al. patents maximum of 35 volt. Therefore the Roe, et. al. device cannot achieve the arousing of the brain. Consequently, after failing to arouse the brain, a series of electrical pulses (Roe, et. al. '308, column 23, lines 38 to 56), together with the whole pulse train cannot cause the building up of the necessary behavioral conditioning, because the electrical pulses are too weak to arouse the brain, and lack the strength to cause an unpleasant reaction.
Another problem of these Roe, et. al. patents lies in the essence of the proactive sensor, which is the basis of the patent. Eliciting behavioral conditioning requires a starting event, which the brain can connect with the following “reward”. In the case considered, this event is the incontinent release of bodily wastes. However, the Roe, et. al. proactive sensor is designed to anticipate the beginning of incontinent release of bodily wastes. Consequently, this basic property of the proactive sensor actually averts in principle the building up of a behavioral conditioning by the brain.
A discrepancy in these Roe, et. al. patents is the confusion which arises from the disclosure of just one EMG electrode (Roe '308, column 23, line 66; column 24, line 5; and column 28, line 17) for the application of electrical impulses delivered from the actuator to the human body. It is well known to those skilled in the art that an application of electrical pulses to the human body can be done by a pair of electrodes. Roe, et. al. do not disclose how the invention is practiced with a single electrode. This uncertainty is not solved even in the more recent Roe, et. al. patent, U.S. Pat. No. 6,570,053 B2 where it lacks any specification for a pair of electrodes. In addition, all electrodes 64, 65 and 66 on FIG. 1 are actually electromyographic measuring electrodes, which receive information on the entrance of the electrical circuit of the proactive sensor 60 and do not apply electrical pulses from the device to the human body.
Another significant problem with the Roe, et. al. proactive sensor, when it is receiving electrical signals emitted by the sphincter muscles, is that “The electrical activity measured by the surface electrodes includes a combination of EMG signals, other physiological signals present on the skin surface such as EKG and electro dermal activity, and environmental artifacts such as 60 Hz from electronic equipment or radio frequency interference.” (Roe '308, column 26, lines 3 to 8). Applying bimodal electrodes in combination with a differential amplifier (Roe '308, column 26, lines 8 to 9) does, however, not avoid electrical signals caused by movements of the lower part of the wearer's body. Furthermore, it is recommended to increase or decrease the electrical activity, whereby for increases three preferred values are given—an increase about 2 times, 3 times and 5 times or more than the basal activity (Roe '308, column 27, lines 3 to 6). For the preferred decrease three preferred values are given, 50%, 75% and 95% (Roe '308, column 27, lines 17 to 20, and claims 7, 8 and 9). It is obvious that these values depend on the needs of the individual wearer.
These uncertainties in the nature of the different signals measured by the Roe, et. al. proactive sensor, as well as the singling out of their direction and optimal degree of change show that the adjustment to the individual wearer has to be made by a highly skilled specialist. Instead of this, the adjustment of the strength of the arousing and behavioral conditioning causing electrical signals of the present invention to the individual sensitivity of the incontinent person, is easy to perform and can be done by the wearer himself, for it is guided by the simple sensing of a feeling as by a pin prick.
The regulator of DiScipio U.S. Pat. No. 4,977,906 is constructed to program the kind and the intensity of visual, audio or tactile signals and not the strength of electrical pulses applied to the human body. The regulator of Roe, et. al. regulates the strength of electrical pulses delivered to the human body but only up to maximum of 30 volt, some ten times less than the strength necessary to arouse the brain and for an inducing of an adverse reaction, necessary to the establishment of behavioral conditioning. Therefore, any exchange of the regulators does not make a device able to build up behavioral conditioning and thereby heal incontinence disorders.
The detector from Brown U.S. Pat. No. 5,036,859 has one advantage over Roe, et. al.'s proactive sensor—that is reacting not before, but after the release of urine (column 4, line 63). Together with this, it has multiple disadvantages for an application on a device created to build up behavioral conditioning. Brown operates by ineffective arousing alarms (column 2, line 51; column 4, lines 41 to 42; column 4, line 67), an adsorbent sheet that delays the starting of the device (column 2, lines 31 to 32; column 8, line 47). Brown operates by remote signaling that delays further the arousing of the incontinent person's brain (column 4, line 67; column 5, lines 2 to 3). Brown is specially designed not for an immediate healing, but relies upon a long time training (column 9, lines 44 to 46). The very complicated electronics, which “includes a transmitter means for sending a coded digital signal” (Brown, column 2, lines 58 to 59) is justified only for an individual monitoring of many incontinent persons in day care centers, hospitals or nursing homes (Brown, column 2, line 44; column 5, lines 21 to 22). Consequently, the combination of the DiScipio or Roe, et. al. devices with the Brown sensor will not provide a device able to build up a behavioral conditioning, because the combined devices will have not only the flaws of the Brown sensor mentioned above, but will also not be able to send the electrical pulses to the human body, necessary for the building up of a behavioral conditioning due to the low voltage of the Roe, et. al. '308 patent,
According to the present invention, the application of electrical pulses with appropriate strength in conformity with achievements of the physiology of learning and behavioral conditioning instead of audio, visual or vibratory arousing signals for arousing the brain, combined with an electrical signal for the building up of a behavioral conditioning makes it possible to shorten the healing period of the incontinent release of bodily wastes from many months to only a few days. The instantaneous cessation of the involuntary release eliminates the further worsening of the situation. The noiseless device worn on the body makes use possible during daytime and even in public places.
The main object of the present invention is to provide a fast-acting programming of the brain to counteract involuntary release of biological fluids by incontinent people.
Another object is to achieve this goal and yet to preserve the privacy of the person, so that it is possible to apply the invention in schools, camps and other public places for the curing not only of nighttime, but also of daytime, wetting and soiling.
Yet another object is to preserve the self-esteem of the involuntarily wetting or soiling person.